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Whats New MARCH 2016 The Greatest of the Latest from Whats True Product Reviews by your Peers of 2 March 2016 www.clinicianreports.com Welcome Thank you for joining us for the Telemedicine issue of Clinician Reports. Inside youll find some of the more interesting technological innovations in healthcare that can help you and your patients thrive. With over 3000 new medical tools and therapies coming to market every year its a challenge to maintain a successful practice and keep abreast of the latest FDA-approved tools and therapies. Were here to help you discover the best in medicine so that you can practice at your best. The Telemedicine issue features a therapeutic collage of peer-reviewed and newly-approved medical tools and therapies with the full spectrum of data that you need to make an informed decision. This issue features product reviews from your peers of GoSafe AGNES Freespira and GoCheck Kids and the top 5 that have to come to market in the last 45 days. Enjoy and we look forward to sharing more innovations in Aprils Infectious Disease and Infection Control issue. To your success The Clinician Reports Team Publisher Clinician Reports Chief Medical Officer Thomas J. Lower DO Editor in Chief Michael S. Lower Creative Director Mandi Moracho Cover Clinician Reports Copyright 2016 by Clinician Reports. All rights reserved under United States International and Pan-American Copyright Conventions. No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means without prior written permission from the publisher. The views and opinions expressed in the articles appearing in this publication are solely those of the author. Neither Clinician Reports nor its affiliates including all authors product reviewers and editorial staff endorse any products medical techniques or diagnoses and publication of any material in this journal should not be construed as such an endorsement. Website www.clinicianreports.com Contact queryclinicianreports.com 3 March 2016 www.clinicianreports.com TABLE OF CONTENTS MARCH 2016 Whats New Whats True page 4 page 10 GoSafe Freespira AGNES Interactive page 16 Eko Core page 18 Propeller System page 19 Halaven page 24 page 25 Briviact REDAPT zensor page 17 page 26 page 28 LC Bead LUMI Omnigraft CAS-One IR page 27 page 8 page 12 GoCheck Kids Onzetra Xsail page 20 EXCLUDER page 22 page 21 Ureteral Stent Tracker Zepatier page 23 Whats True 4 March 2016 www.clinicianreports.com GoSafe GoSafe is a mobile personal emergency response service mPERs from Philips Lifeline. Designed for 247 use users wear the GoSafe mobile pendant both at and away from home. Should they need assistance the user can activate the pendant to initiate a help call to the Lifeline Response Center or in the event a fall is detected the AutoAlert fall detection feature will automatically place the call.1 While in the home the GoSafe button works in conjunction with the GoSafe in-home communicator. This helps to optimize overall system performance and reliability and provides the Lifeline Response Center with a location of the user. If help is needed away from home2 GoSafe is equipped with a cellular two-way speakerphone and a suite of locating technologies. Together these features assist the Lifeline Response Center in communicating with and locating the user and ultimately getting the help they request as quickly as possible. At home or away the user is able to speak directly to the Lifeline response center through the pendant to help provide clear voice communication. The GoSafe system includes Philips AutoAlert fall detection capabilities along with the combined advantage of up to seven locating technologies including from the FDA Two-way voice communication In-home communicator Wi-Fi locating Assisted GPS Intelligent bread crumbs Audio beacon 1 AutoAlert does not detect 100 of falls. If able the user should always push their button if they need assistance. Button signal range may vary due to environmental factors. 2 Coverage outside the home provided where ATT wireless network coverage is available. No additional wireless equipment is needed. A customer phone number is required to enroll in the service. 5 March 2016 www.clinicianreports.com TELEMEDICINE clinical results peer reviews product site product video FDA warnings order Clinician Reports asked healthcare practitioners to review GoSafe. GoSafe was tested against 6 key criteria and each was graded on an A through F scale. Product quality Service reliability Fall detection technology Mobile option GPS locating technology Protects my patients Patient caregiver satisfaction OVERALL FINAL GRADE AA A A A A A Philips Lifeline with GoSafe allows my patients to have the access to help I have always expected from Lifeline whether away from home or in the home. I know when our McLaren patients sign up with Philips they have acces to help when our nurses are no longer caring for them. We are still able to connect back using Lifelines care alerts to provide our patients with continued care if and when it is needed from our agency. I encourage my staff to share the benefits of Lifeline with our patients. Tara Chilcote RN Clinical Supervisor Tara Chilcote RN Clinical Supervisor Whats True 6 March 2016 www.clinicianreports.com The Philips Lifeline GoSafe system is something all seniors as well as anyone at risk for falls should have in their home. The cost is minimal for the peace of mind that it gives to not only the individual but the family. Moreover the fact that a person can also use it to call for emergency assistance is a definite plus. Similarly the ability to get a real person to respond within seconds adds an extra layer of protection. I especially like that the responder calls the individualsenior by name. Product quality A Service reliability A Fall detection technology A Mobile optionGPS locating technology A Protects my patients A Patient caregiver satisfaction A OVERALL FINAL GRADE A Miriam Colon MSW This is a wonderful product that has allowed many of my homecare patients the opportunity to get access to assistance in a time of crisis. Having this system has allowed many of them to remain independent in their home and community with peace of mind not only for themselves but their loved ones as well. Product quality A Service reliability A Fall detection technology A Mobile optionGPS locating technology A Protects my patients A Patient caregiver satisfaction A OVERALL FINAL GRADE A Rachel Bamber LCSW Product quality Service reliability Fall detection technology Mobile optionGPS locating technology Protects my patients Patient caregiver satisfaction OVERALL FINAL GRADE AA A A A A AAmy Wileman Care Manager Lifeline is dependable. The equipment is easy to use and the staff is friendly and courteous. Product quality Service reliability Fall detection technology Mobile optionGPS locating technology Protects my patients Patient caregiver satisfaction OVERALL FINAL GRADE AA A A A A ALorenza Torres COTAL DOR GoSafe alert system has helped my patients stay independent in their home apartment. GoSafe is reliable. Patients who have GoSafe are very satisfied with their product and service. GoSafe 7 March 2016 www.clinicianreports.com TELEMEDICINE The Lifeline system is simply the best. It is GPS-enabled. The help button is waterproof and comes with its own speaker and microphone. It can be worn in or out of the home. Just keep the button charged a few moments a day then place it around her neck. Product quality A Service reliability A Fall detection technology A Mobile optionGPS locating technology A Protects my patients A Patient caregiver satisfaction A OVERALL FINAL GRADE A Bill Givans PRMC Volunteer I think GoSafe is a good product. It give patients peace of mind and a sense of security especially those who live alone or have fallen in the past. One of my patients even uses it as a home alarm system. I would recommend this product for any senior disabled individual. Product quality A Service reliability A Fall detection technology A Mobile optionGPS locating technology NA Protects my patients A Patient caregiver satisfaction A OVERALL FINAL GRADE A Kimberly Alderson ACSWLCSW It seems like most clients will purchase the least expensive service. I will recommend a medium cost and promote that product making sure they are all waterproof and do not look like an institution necklace or bracelet. Product quality A Service reliability A Fall detection technology A Mobile optionGPS locating technology B Protects my patients A Patient caregiver satisfaction A OVERALL FINAL GRADE A- McAnna Cooper SSC Whats True 8 March 2016 www.clinicianreports.com AGNES Interactive AGNES Interactive is a collaborative patient assessment tool for telemedicine clinical exams. It is a web-based telemedicine software that enables remote clinical healthcare providers to capture and share medical device data exchange documents and medical images in real-time and participate in a live video conference - all in a single web-based platform. Features include from the FDA Clinician Reports asked healthcare practitioners to review AGNES Interactive. AGNES Interactive was tested against 6 key criteria and each was graded on an A through F scale. Easy-to-use intuitive interface Clinically effective Flexibility to add additional specialties Delivers live access to patient for clinical exams Experience with AMD for support Likelihood of going with this solution again OVERALL FINAL GRADE AA A A A A A Margaret Hall FNP-BC AMD offers outstanding clinical application for the delivery of healthcare via telemedicine. The ease of using the program and hand held devices supports the clinical experience of the provider. Real-time audio and video between the originating and distant sites allows for a fluid clinical visit. We are very pleased with the quality of images and audio capabilities that transmit from our medical devices stethoscope otoscope highscope camera derm camera and vascular doppler. The ability to capture and store images is useful to the providers and contributes to documentation. Easy-to-use intuitive interface Clinically effective Flexibility to add additional specialties Delivers live access to patient for clinical exams Experience with AMD for support Likelihood of going with this solution again OVERALL FINAL GRADE AA A A A A A Andrew Whitney Director of Telemedicine Services Bryan Health Using AMD AGNES on our telemedicine carts allows us to bring a higher level of clinical care to our telemedicine encounters. This level of care differentiates us from other providers of rural emergency department telemedicine that are more consultive in nature. Our rural emergency telemedicine physicians are performing diagnostic evalutions and providing treatment allowing local providers relief from 247 call-ins. The flexibility of the AGNES platform has also allowed us to bring outpatient specialties to rural areas with minimal investment on the part of the specialty physician. Delivers 100 live access to a Patient from any remote location Transmission of all medical data is done in real-time and does not rely on any content sharing applications. Provides complete Physician mobility Remote users have secure web-based access to exam site. Eliminates stethoscope hardware at receive side Provides interface to connect a USB digital stethoscope to stream live heartlung sounds to the remote physician. Enables live Video Conferencing Clinician and remote specialist can teleconference using the included point-to-point video module. Integrates with over 40 medical devices Integrates with any EMR Universal HL7 module allows you to save session information directly to your EMR of choice with a single configuration files. Installed and operational in minutes with no back-end servers needed 9 March 2016 www.clinicianreports.com TELEMEDICINE clinical results peer reviews product site product video FDA warnings order Easy-to-use intuitive interface Clinically effective Flexibility to add additional specialties Delivers live access to patient for clinical exams Experience with AMD for support Likelihood of going with this solution again OVERALL FINAL GRADE BA A B A B A Nick OHare Director of Strategy and Commercial Affairs Mediserve HomeCare AMD is the way of the future. It has allowed us to increase efficiency reduce waiting times for patients and provide more comprehensive consultations in a home visit scenario. Our patient satisfaction rating is in excess of 95 and we see ourselves increasing significantly the use of this technology over the coming months. Easy-to-use intuitive interface Clinically effective Flexibility to add additional specialties Delivers live access to patient for clinical exams Experience with AMD for support Likelihood of going with this solution again OVERALL FINAL GRADE AA A A A A A Jason Peoples Regional E-Health Coordinator Carle Foundation Hospital Utilizing AGNES Interactive has been a staple in the growth of our telehealth initiatives. AGNES Interactive reduces the reliance on robust and costly telepresence infrastructures to a simple web-based platform that provides clincal diagnostic device integration and real-time audio visual interactions from clinician to patients at remote sites. With the stigma of one-more-thing a reality for clinicians ease of use is a key differentiator in the evaluation of telehealth platforms. With physicians and clinical staff alike AGNES Interactive provides a solid foundation and simplicity that enable clinicians to integrate telehealth technology as an extension of the clinical practice easily and efficiently. Easy-to-use intuitive interface Clinically effective Flexibility to add additional specialties Delivers live access to patient for clinical exams Experience with AMD for support Likelihood of going with this solution again OVERALL FINAL GRADE AA A A A A A Leslie Bubba Arnold President St. Vincent Health The telemedicine cart is very good. Weve had a few minor issues but have been able to resolve them quickly. The AGNES software is user friendly and easily meets the needs of our hospitalist service. AMDs service has been exceptional in every way. Easy-to-use intuitive interface Clinically effective Flexibility to add additional specialties Delivers live access to patient for clinical exams Experience with AMD for support Likelihood of going with this solution again OVERALL FINAL GRADE AA A A A A AJoy Xu MD The AGNES telemedicine system changes the Chinese healthcare landscape and creates an entirely new user experience for the customer by offering the luxuries of personalization and convenience. With telemedicine Chinese users have the power of accessibility in their hands to make appointments with American specialists when seeking a 2nd opinion for their difficult medical cases. The AGNES telemedicine system delivers live access to the patient for clinical exams as well as storage users medical records which are important to building stronger relationships between patients and doctors. Whats True 10 March 2016 www.clinicianreports.com Freespira Freespira is intended for use as a treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as a treatment of symptoms associated with panic disorder to be used under the direction of a healthcare professional together with other pharmacological andor non-pharmacological interventions. Freespira provides biofeedback based respiratory training to patients with panic disorder. It is intended to train the patient to control their respiratory rate and end-tidal CO2 levels which may allow the patient to alleviate abnormal breathing and therefore stress associated with panic attacks. It provides the user with a series of tone-guided breathing exercises and an awareness of his or her physiological data to teach the patient to regulate their end-tidal CO2 EtCO2 and respiratory rate RR. The users physiological data display allows the patient to see 1 the actual rate of their breathing and 2 how changes in breathing mechanics depth and volume affect EtCO2 levels. Freespira consists of a biofeedback training software program mobile app and an EtCO2 sensor capnometer used with a nasal cannula. The mobile app guides the user through an exercise and displays physiological data while the sensor collects physiological data and feeds it to the mobile application for biofeedback. The patients EtCO2 levels and RR are relayed from the capnometer to the mobile application via Bluetooth and are displayed on a tablet device through the mobile application. More... Clinician Reports asked independent practitioners to review Freespira. Freespira was tested against 7 key criteria and each was graded on an A through F scale. Efficacy Easy to learn Easy to train my patients Patient compliance Patient satisfaction Product support Easy to integrate into my practice OVERALL FINAL GRADE A-B A A A B A B Kimberly Morrow LCSW Freespira is an easy to use system that will help retrain your brain to breathe in a way that will help prevent panic attacks and decrease anxiety. It is a system that can be used alone but has even more benefits in conjunction with cognitive behavioral therapy. This system is simple to teach and your clients data is easy to retrieve which helps you follow their progress. Every one of my clients that has used Freespira has seen benefits after using this system. from the FDA 11 March 2016 www.clinicianreports.com ANXIET Y Efficacy Easy to learn Easy to train my patients Patient compliance Patient satisfaction Product support Easy to integrate into my practice OVERALL FINAL GRADE AA A A A- A A A Veronika Gold MFT The System teaches you how to breathe in a way that reduces symptoms of anxiety and panic attacks in as little as two to four weeks. The System uses a sensor that measures the CO2 levels in your exhaled breath and transmits the data into an application on a tablet and you use this biofeedback to adjust your breathing pattern. My clients have benefited greatly from using the Freespira Breathing System. Efficacy Easy to learn Easy to train my patients Patient compliance Patient satisfaction Product support Easy to integrate into my practice OVERALL FINAL GRADE A-B B A- A A A A Debra Kissen Ph.D. M.H.S.A. This tool is very helpful in addition to traditional CBT for panic disorder. It is much more effective than trying to offer breathing retraining to clients minus biofeedback. Efficacy Easy to learn Easy to train my patients Patient compliance Patient satisfaction Product support Easy to integrate into my practice OVERALL FINAL GRADE AA A A A A A A Neal Sideman Co-Chair of the ADAA Public Education Committee The biofeedback training takes 17 minutes twice-a-day for 4 weeks. Ive been following the research on this approach for 14 years and top people in the field have been in the forefront. Recent clinical trials show that after 4 weeks over 80 show substantial reduction in panic symptoms and about 50 no longer meet criteria for panic disorder. In my opinion Freespira is compatible with both CBT and medication and is also highly effective as a standalone treatment. I find it easy to teach my clients how to use Freespira and the customer support is outstanding. Efficacy Easy to learn Easy to train my patients Patient compliance Patient satisfaction Product support Easy to integrate into my practice OVERALL FINAL GRADE A-B A A A B A B Sandra Carusa Ph.D. Some of the positives are that Freespira is backed up by good research it is a great biofeedback system wish it monitored more physiological anxiety indicators even patients with cognitive difficulties can learn to use the system. Unfortunately I have not had a straight panic patient without other anxiety disorders or complications since I have been using Freespira. With the patients that have used the device I have had great compliance and I have seen a global reduction in anxiety. With the majority of patients I can see more of a difference than the patients see in themselves. That being said I believe the patient satisfaction is high. Freespira professional support had been great and I like that I am removed from the patient payment aspect of Freespira. The cost has kept some patients from choosing Freespira. clinical results peer reviews product site product video FDA warnings order Whats True 12 March 2016 www.clinicianreports.com GoCheck Kids is the first and only smartphone app that uses photoscreening to detect risk factors for amblyopia the 1 cause of childhood blindness. Using a smartphones camera and flash the GoCheck Kids app detects and analyzes a childs retinal red reflex to help pediatricians determine amblyopia risk factors including anisometropia myopia and hyperopia. The software analyzes a single photo of the eyes and provides an immediate result. The GoCheck Kids photoscreening app works by using sophisticated algorithms and technology designed by ophthalmologists. The GoCheck Kids app was co-invented by David Huang MD PhD who also contributed to the development of optical coherence tomography OCT imaging technology. OCT is one of the most widely used technologies for refractive surgery and other medical and diagnostic purposes. More... from the FDA GoCheck Kids 13 March 2016 www.clinicianreports.com PEDIATRIC VISION Clinician Reports asked independent practitioners to review GoCheck Kids. GoCheck Kids was tested against 6 key criteria and each was graded on an A through F scale. Easy to integrate into your practice Easy to use Efficient Patient friendly Clinically effective Good business for your practice OVERALL FINAL GRADE AA A A A A A Awesome technology that allows me to diagnose problems that are otherwise impossible for me to find without referral to Specialists. GoCheck Kids staff are extremely helpful as well as listening for possible upgrades improvements suggested by the users of the technology. Shannon Kluppel MD Shannon Kluppel MD clinical results peer reviews product site product video FDA warnings order Whats True 14 March 2016 www.clinicianreports.com Easy to integrate into your practice Easy to use Efficient Patient friendly Clinically effective Good business for your practice OVERALL FINAL GRADE A-C A A A A B GoCheck Kids is a kid-friendly physician-friendly solution for screening young eyes early on for risk factors that pose serious threats to their vision if left untreated. Anchorage Pediatric Group has easily incorporated the use of these screening devices into annual Well Child Checkups. The integration of a third party device results with our current EHR system comes with challenges just like any other integration but Gobiquity has made excellent regular advancements toward improving the integration. Brice Alexander Practice Administrator Anchorage Pediatric Group Easy to integrate into your practice Easy to use Efficient Patient friendly Clinically effective Good business for your practice OVERALL FINAL GRADE BB B B B A- A The major issue with this product is the software glitches that seem to happen very often. After a short training period the nurses are pretty efficient with this tool. The pictures taken and the reports are very helpful. When it is working well it is terrific tool to have. Harry Pellman MD Harry Pellman MD GoCheck Kids 15 March 2016 www.clinicianreports.com PEDIATRIC VISION Very easy set up. Excellent support team. All technical issues handled professionally and quickly. Adds some clinical time to explain intent and value of use to patients. Easy to integrate into your practice A Easy to use B Efficient A Patient friendly A Clinically effective B Good business for your practice NA OVERALL FINAL GRADE A Natasha Burgert MD Overall we have been pleased with GoCheck Kids. There are technical issues from time to time but overall it works well. Clinically effective overall. Parents really like the screening. Easy to integrate into your practice A Easy to use B Efficient A- Patient friendly A Clinically effective B Good business for your practice A OVERALL FINAL GRADE A Julia White MD FAAP Overall we have had a positive experience with the GoCheck Kids programs. Occasional issues include difficulty obtaining an appropriate image because of incorrect distance from patient or patient non- compliance. Some of the younger 6-12 mo children are difficult to get good images of because they dont look at the screen. However the app has given us a more reliable vision screen for young children. Jennifer Robert PA-C Easy to integrate into your practice Easy to use Efficient Patient friendly Clinically effective Good business for your practice OVERALL FINAL GRADE AA B B A- A A Jennifer Robert PA-C 16 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings TELEMEDICINE The Eko Electronic Stethoscope System is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs bruits respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac vascular pulmonary or abdominal organ systems. The Eko Core attaches to almost any existing analog stethoscope. You dont need to cut the tube tubing adaptors are included. It provides seamless analog and digital sound and wirelessly transmits the stethoscope audio via Bluetooth to a smartphone or tablet. Eko Core features More... from the FDA Eko Core Analog and digital modes. Audio amplification in digital mode. Works with heart lung and body sounds. Rechargeable battery. 7 amplification levels. 17 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings TELEMEDICINE zensor The zensor monitoring device is a small lightweight wearable non-invasive re-chargeable battery operated system connected to an electrode accessory single-use disposable Intelesens zensor Electrode Array which in turn is in contact with the patients body. The device is to be used in the home environment to provide clinicians with patient physiological data. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The zensor monitoring system displays ECG and respiration waveforms from the zensor monitoring device. The system monitors the following configurable physiological parameters Heart Rate and Respiration Rate as well as key cardiac arrhythmias and a patient activated recording. The zensor monitoring system has the option to store full disclosure ECG Respiration and accelerometer data andor wirelessly transmit pre- defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be imported for viewing on Intelesens zensor Ambulatory Full Disclosure ECG and Event Viewer for later analysis by a clinician. More... from the FDA 18 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings TELEMEDICINE The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records stores and transmits usage events from Propeller Sensors or via manual user entry to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers physician and healthcare providers. The Propeller Web Application is software that like the Propeller Mobile Application is intended to allow users to review the collected information and characteristics of their MDI and its use to capture other patient-reported information and outcomes and to allow that information to be shared with their caregivers physicians and health care providers. When together with a prescribed MDI the system can report on information captured during the normal course of use such as the time between actuations that can be helpful in assessing MDI technique. More... from the FDA Propeller System 19 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings LIPOSARCOMA Halaven Halaven eribulin mesylate a type of chemotherapy is indicated for the treatment of liposarcoma a specific type of soft tissue sarcoma that cannot be removed by surgery unresectable or is advanced metastatic. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. Soft tissue sarcoma STS is a disease in which cancer cells form in the soft tissues of the body including the muscles tendons fat blood vessels lymph vessels nerves and tissues around joints. Liposarcoma is a specific type of STS that occurs in fat cells. STS can form almost anywhere in the body but is most common in the head neck arms legs trunk and abdomen. In 2014 an estimated 12000 cases of STS were diagnosed in the United States according to the National Cancer Institute. The efficacy and safety of Halaven were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes locally advanced or other parts of the body metastatic and who had been treated with chemotherapy. The median overall survival for patients with liposarcoma receiving Halaven was 15.6 months compared to 8.4 months for those who received dacarbazine. More... from the FDA 20 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings MIGR AINE Onzetra Xsail is a nasal powder formulation of sumatriptan a serotonin 5-HT1B1D receptor agonist. It is specifically indicated for the acute treatment of migraine with or without aura in adults. Onzetra Xsail is supplied as a powder for intranasal administration delivered with the Xsail breath-powered delivery device only. The recommended dose is 22 mg administered by use of one nosepiece 11 mg in each nostril. The maximum dose in a 24-hour period should not exceed two doses 44 mg separated by at least 2 hours. FDA approval of Onzetra Xsail was based on a multicenter randomized double-blind placebo-controlled study in subjects with moderate to severe migraine headache. The proportion of patients who had headache relief defined as a reduction from moderate or severe pain to mild or no pain was assessed at 15 30 60 90 minutes and 2 24 and 48 hours after treatment with study drug. The percentage of patients achieving headache relief 2 hours after treatment was significantly greater in the Onzetra Xsail 22 mg group compared to those who received placebo 68 vs. 45. For patients with migraine associated nausea photophobia and phonophobia at baseline there was a lower incidence of these symptoms at 2 hours following administration of Onzetra Xsail compared with placebo. More... from the FDA Onzetra Xsail 21 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings TELEMEDICINE Ureteral Stent Tracker The Ureteral Stent Tracker is a digital solution to record and monitor ureteral stent placements. It is designed to help reduce the risk of forgotten stents. Available as a mobile app or web portal the HIPAA- compliant platform allows users to create a patient care plan when the stent is placed enter in the extraction due date and receive recurring email reminders about the status of stent placements. Studies show that 13 of ureteral stents are forgotten removed later than six months and at six months 76 of stents are encrusted. Encrustation leads to higher risk of infection and obstruction and results in an average of 2 surgical procedures for stent removal. Using a digital tracking solution reduces forgotten stents from 13 to 1. The Ureteral Stent Tracker is designed to reduce human error and increase efficiency of tracking stents and to minimize complications due to forgotten encrusted stents. More... from the FDA 22 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings ANEURYSM The GORE EXCLUDER Iliac Branch Endoprosthesis IBE is the first off- the-shelf aortic branch device approved in the United States and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. It is made of the same ePTFE and nitinol materials as and is used along with the GORE EXCLUDER AAA Endoprosthesis to isolate the common iliac and motivate the flow through the external iliac and internal iliac arteries. The Excluder AAA device has treated more than 250000 since receiving a CE mark in 1997 and FDA approval in 2002. The devices come in a range of sizes from 6.5 to 13.5 mm for interla iliac arteries and from 6.5 to 25 mm for the external iliacs. The device is installed using a delivery catheter and 16 French 5.33 millimeter in diameter introducer sheath in the case of the iliac branch component and 12 French 4 millimeter introducer sheath in the case of the internal iliac component. The GORE EXCLUDER Iliac Branch Endoprosthesis has already been approved for implantation in Europe since 2013. More... from the FDA EXCLUDER 23 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings HEPATITIS C Zepatier Zepatier elbasvir and grazoprevir is indicated with or without ribavirin for the treatment of chronic hepatitis C virus HCV genotypes 1 and 4 infections in adult patients. According to the Centers for Disease Control and Prevention approximately 3 million Americans are infected with HCV of which genotype 1 is the most common and genotype 4 is one of the least common. The safety and efficacy of Zepatier with or without ribavirin was evaluated in clinical trials of 1373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received Zepatier with or without ribavirin once daily for 12 or 16 weeks. The studies were designed to measure whether a participants hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment sustained virologic response or SVR suggesting a participants infection had been cured. The overall SVR rates ranged from 94-97 percent in genotype 1-infected subjects and from 97-100 percent in genotype 4-infected subjects across trials for the approved treatment regimens. Zepatier was granted breakthrough therapy designation for the treatment of chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection. More... from the FDA 24 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings EPILEPSY Briviact brivaracetam is indicated as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. Brivaracetam is a selective high-affinity synaptic vesicle protein 2A ligand is an analogue of the already available antiepileptic drug levetiracetam. Approximately 5.1 million people in the United States have a history of epilepsy and approximately 2.9 million people in the United States have active epilepsy. Briviacts effectiveness was studied in three clinical trials involving 1550 participants. One phase 3 trial included 768 patients aged 16 to 80 years with drug-resistant POS at 206 sites worldwide. For both doses of the drug the co-primary efficacy outcomes were statistically significant P .001 compared with placebo. The percentage reduction over placebo in the 28-day adjusted POS frequency was 22.8 for the 100-mg group and 23.2 for the 200-mg group. The other co-primary outcome a 50 or greater responder rate for POS frequency showed that this rate was 21.6 for placebo vs. 38.9 for the 100-mg dose P .001 and 37.8 for the 200-mg dose P .001. The median percentage reduction in POS frequency was 37.2 for the 100-mg dose and 35.6 for the 200-mg dose compared with 17.6 for placebo both P .001. More... from the FDA Briviact 25 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings ORTHOPEDICS REDAPT The REDAPT Porous Acetabular Shell allows for the cementing of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation. The REDAPT Cemented Liner is manufactured from highly cross-linked polyethylene ASTM F648 via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle. The REDAPT Porous Acetabular Shell and Cemented Liner are indicated for Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease NIDJD or any of its composite diagnoses of osteoarthritis avascular necrosis traumatic arthritis slipped capital epiphysis fused hip fracture of the pelvis and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis arthritis secondary to a variety of diseases and anomalies and congenital dysplasia treatments of nonunion femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques endoprosthesis femoral osteotomy or Girdlestone resection fracture- dislocation of the hip and correction of deformity. More... from the FDA 26 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings LIVER CANCER LC Bead LUMI is the first commercially available radiopaque embolic bead cleared by the US Food Drug Administration FDA for the embolization of hypervascular tumors and arteriovenous malformations AVMs. It provides visible confirmation of bead location during AVM procedure. LC Bead LUMI is an imageable spherical embolic product that can be visualized by X-ray based imaging e.g. fluoroscopy and CT. The beads are non-resorbable microspheres with calibrated size ranges and are supplied in a saline buffer solution within a sealed glass vial. A vial access device is also provided within the secondary packaging. LC Bead LUMI consists of a macromer derived from a sulphonate modified polyvinyl alcohol PVA macromer which contains a radiopaque moiety that is covalently bound within the hydrogel structure. The incorporation of this radiopaque moiety into the co-polymer imparts Xray imageability by rendering the microspheres radiopaque. At the time of use LC Bead LUMI is mixed with non-ionic contrast agent in order to monitor the delivery of the product during the embolization procedure. It is delivered via typical microcatheters to physically block the target vessel. Once the product has been delivered the iodine moiety allows for visualization of the microspheres. LC Bead LUMI is a single use tissue contacting implantable device available only for prescription use. More... from the FDA LC Bead LUMI 27 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings DIABETIC FOOT ULCERS Omnigraft Omnigraft is indicated to treat certain diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule tendon or bone when used in conjunction with standard diabetic ulcer care. The matrix device which is made of silicone cow collagen and shark cartilage is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound. An estimated 29 million people in the United States have been diagnosed with diabetes according to the Centers for Disease Control and Prevention and about 25 percent of them will experience a foot ulcer during their lifetime. Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50000 amputations each year. Omnigrafts indication is based on a clinical study that demonstrated that the matrix device improved ulcer healing compared to standard diabetic foot ulcer care which includes cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer. In the study 51 percent of patients treated with Omnigraft had healed ulcers after 16 weeks compared to 32 percent of patients treated with standard diabetic foot ulcer care alone. More... from the FDA 28 March 2016 www.clinicianreports.com Whats New clinical results peer reviews product site product video orderFDA warnings GUIDED SURGERY CAS-One IR is a user controlled stereotactic accessory intended to assist in planning navigation and manual advancement of one or more instruments as well as in verification of instrument position and performance during Computed Tomography CT guided procedures. In planning the desired needle configuration and performance is defined relative to the target anatomy. In navigation the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored. In verification the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data. CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures. The system consists of these main components A mobile navigation platform that includes two touch screens a camera and a computer An aiming device with two possible configurations and a trackable aiming insert An instrument adapter clamp with a trackable marker shield CAS-One IR software which provides the step-by-step workflow assistance More... from the FDA CAS-One IR